The need to grow and diversify product portfolios drives innovation and consolidation. We support medical device and related technology companies facing transformational change and significant regulatory or legal pressures as they work to respond to, anticipate, and plan for the changing healthcare landscape. Our team has decades of experience and a deep understanding of the industry. We bring together global teams with specific knowledge of local market dynamics, in both developed and emerging markets, to help our clients build, manage, and protect their businesses.
We provide strategic market assessments, tactical geography planning, market landscape analysis, and detailed strategies to help companies reach their full potential in the U.S. and around the world.
We help create new ways of demonstrating product value to meet the needs of each market.
We devise and improve quality and regulatory strategy and respond to the FDA/EMA and related agencies around the world.
We help navigate emerging regulations around innovative technologies.
We develop, implement, and evaluate compliance programs.
We respond quickly and efficiently to government investigations and regulatory action.
We assist with all aspects of the product life cycle, from concept and product realization to market development and go-to-market strategies to obsolescence.